Cleared Traditional

K251767 - Vena MicroAngioscope System

K251767 is an FDA 510(k) clearance for Vena MicroAngioscope System, manufactured by Vena Medical Holdings Corp. The device is a Class 2 Cardiovascular device with product code LYK cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K251767 · Vena Medical Holdings Corp · Cardiovascular device
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Oct 2025
Decision
113d
Days
Class 2
Risk

K251767 is an FDA 510(k) clearance for the Vena MicroAngioscope™ System. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Vena Medical Holdings Corp (Kitchener, CA). The FDA issued a Cleared decision on October 1, 2025 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 876.1500 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vena Medical Holdings Corp devices

FDA 510(k) Submission Details - K251767

510(k) Number K251767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2025
Decision Date October 01, 2025
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYK Device Classification - Class 2, Special Controls

Product Code LYK Angioscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LYK Angioscope

All 19
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K251767.
Vena MicroAngioscope™ System
K253842 · Vena Medical Holdings Corp · Jan 2026
KSEA FIBERSCOPE
K011793 · KARL STORZ Endoscopy-America, Inc. · Apr 2002
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · Smith & Nephew, Inc. · Nov 2001
KSEA VASCULAR FIBERSCOPES
K001408 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
K964061 · W.L. Gore & Associates, Inc. · Feb 1997
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE
K951721 · Applied Medical Resources · Jul 1995